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Janssen Single-Dose COVID-19 Vaccine is Pending FDA Emergency Use Authorization

  • by Steve Nesnidal, MD, CPC, AHFI
  • Feb 23, 2021, 09:34 AM

On February 4,  2021, Janssen Biotech, Inc. applied to the FDA for Emergency Use Authorization (EUA) of its single-dose COVID-19 vaccine. The vaccine’s safety and efficacy data, among other info, will be reviewed by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) in a meeting scheduled for February 26.

Janssen Vaccine Might Be a Necessary Bullet in the Global Fight Against COVID-19

The vaccine has several pertinent characteristics that suggest in may be highly desirable in fighting COVID-19:

  • It is compatible with standard vaccine distribution channels
  • It has good efficacy numbers as a single-dose vaccine
  • It can be stored at least three months in most standard refrigerators

Based on Phase III efficacy data released from the ENSEMBLE study on January 29, Janssen’s single-dose vaccine was:

  • 72% effective in the U.S.
  • 66% effective overall at preventing moderate to severe COVID-19 illness 28 days after vaccination
  • 85% effective overall in preventing severe disease
  • Demonstrated 100% protection against COVID-19 related hospitalization and death on Day 28

Janssen, a division of Johnson & Johnson, used their AdVac vaccine technology platform to develop the vaccine; this platform is the same one the company used for developing and manufacturing its European Commission-approved Ebola vaccine regimen, as well as for constructing the investigational Zika, RSV, and HIV vaccines. Over 200,000 people have already received vaccines based on this platform.

AMA Prepares for Authorization

The AMA has already created a pair of vaccine administration/toxoid codes for use in reporting this Johnson & Johnson/Janssen Biotech vaccine:

  • 91303 – Janssen Biotech’s COVID-19 vaccine TOXOID
  • 0031A – ADMINISTRATION of single dose of Janssen Biotech’s vaccine

These codes will become effective on the date of the FDA’s EUA of the vaccine.

Context4 Healthcare Customers Stay in the Loop

As always, our products will include the latest rules and codes according to industry updates.

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